JIS T 0601-1:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
Hardcopy
04-04-2023
Japanese
03-01-2017
Introduction1 Scope, object and related standards2 Normative references3 Terms and definitions4 General requirements5 General requirements for testing ME EQUIPMENT6 Classification of ME EQUIPMENT and ME SYSTEMS7 ME EQUIPMENT identification, marking and documents8 Protection against electrical HAZARDS from ME EQUIPMENT9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME SYSTEMS10 Protection against unwanted and excessive radiation HAZARDS11 Protection against excessive temperatures and other HAZARDS12 Accuracy of controls and instruments and protection against hazardous outputs13 HAZARDOUS SITUATIONS and fault conditions14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS15 Construction of ME EQUIPMENT16 ME SYSTEMS17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMSAnnex A (informative) - General guidance and rationaleAnnex B (informative) - Sequence of testingAnnex C (informative) - Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMSANNEX D (informative) - Symbols on markingAnnex E (informative) - Examples of the connection of the measuring device (MD) for measurement of the PATIENT LEKAGE CURRENT and PATIENT AUXILIARY CURRENTAnnex F (informative) - Suitable measuring supply circuitsAnnex G (normative) - Protection against HAZARDS of ignition of flammable anaesthetic mixturesAnnex H (informative) - PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentationAnnex I (informative) - ME SYSTEMS aspectsAnnex J (informative) - Survey of insulation pathsAnnex K (informative) - Simplified PATIENT LEAKAGE CURRENT diagramsAnnex L (normative) - Insulated winding wires for use without interleavedBibliographyAnnex JA (informative) - Index of defined terms Annex JB (informative) - Index of abbreviations and acronymsAnnex JC (informative) - Comparison table between JIS and corresponding International Standard
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